New Rules for FDA Regulation of Lab Developed Diagnostic Tests (LDT)

Date: January 21, 2024
Duration: 60 Minutes
Time: 12 PM EST

Currently there are more than 4000 LDTs offered by hundreds of lab across the country subject to the LDT rules. Although FDA does not actively regulated LDTs, it has policies to encourage better testing and marketing of LDTs to consumers. Under the LDT rules, LDTs are reviewed based on the perceived risk and providers are expected to maintain records for validation, testing, and use of such tests. In the near future, FDA intends to apply enforcement discretion for the premarket approval requirements and quality system regulations, but these discretions may change in next few years.

Why should you attend:
FDA has expressed its desire to create rules to better regulate LDTs. This seminar will discuss the current rules and practical tips for being compliant to the current rules. The instructor will provide advice based on his extensive regulatory experience on the best and worst case scenarios for various kinds of LDTs under current regulations. This seminar is intended for general instructions to all LDT providers such as laboratories, clinics, physicians, hospitals, reimbursement experts, clinical trial users, and regulators who wish to have a better understanding of how FDA regulates LDTs.

Areas Covered in the Session:

Definition of LDTs and differences and similarities with other diagnostics
Current FDA regulations and guidance documents
Documentation required
Quality systems currently applicable to LDT providers
Labeling and marketing practices

Who will benefit:

Senior management of LDT providers
Project Managers
Regulatory Vice Presidents, Directors and Managers
Lab testing professionals
Compliance professionals
Auditors
Attorneys – In-house or Outside Counsel

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal.

Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.